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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K032149
Device Name RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
Applicant
Rita Medical Systems, Inc.
967 N. Shoreline Blvd.
Mountain View,  CA  94043
Applicant Contact KAREN J FRISCHMEYER
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/14/2003
Decision Date 09/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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